Medication info

Empagliflozin/Metformin 5/850 mg Tablet

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
구주제약(주)
Appearance
White, oval, biconvex, film-coated tablet with a yellow tint
Packaging
10 tablets/box [10 tablets/PTP X 1], 60 tablets/box [10 tablets/PTP X 6], 60 tablets/bottle
Approval status
Active

MFDS item code 202201393 · Approved 2022.04.04

Summary

Main use
Effectiveness in blood sugar control and prevention of cardiovascular events in type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet once, twice a day. It should be determined considering each patient's treatment regimen, efficacy, and tolerability, so that total daily doses do not exceed 25 mg of empagliflozin and 2000 mg of metformin. For patients who do not achieve adequate glycemic control, 5 mg of empagliflozin taken twice daily (total daily amount of 10 mg) in addition to their existing metformin dosage is recommended. If tolerability is good, the dose may be increased to 25 mg of empagliflozin.

Ingredients

Manufacturer
구주제약(주)

Efficacy & effects

Effectiveness in blood sugar control and prevention of cardiovascular events in type 2 diabetes

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular disease
View approved original text

This medication contains both empagliflozin and metformin to assist adults with type 2 diabetes in controlling blood sugar as an adjunct to diet and exercise therapy. It is particularly suitable for patients with cardiovascular disease who do not achieve adequate glycemic control. For details on the impact on cardiovascular events, please refer to the usage precautions provided by professionals. Overall, this medicine improves blood sugar control and is helpful in treating type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once, twice a day. It should be determined considering each patient's treatment regimen, efficacy, and tolerability, so that total daily doses do not exceed 25 mg of empagliflozin and 2000 mg of metformin. For patients who do not achieve adequate glycemic control, 5 mg of empagliflozin taken twice daily (total daily amount of 10 mg) in addition to their existing metformin dosage is recommended. If tolerability is good, the dose may be increased to 25 mg of empagliflozin.

Precautions

This medication helps in blood sugar control. Care must be taken while using this medication as it may cause a rare but very dangerous condition known as severe lactic acidosis. Lactic acidosis occurs when lactic acid builds up excessively in the body and can be life-threatening in severe cases. Additionally, when used with other diabetes medications such as insulin or sulfonylureas, caution must be exercised as hypoglycemia (symptoms of low blood sugar) may occur. This drug should not be used in patients with severely impaired kidney function, acute infections, dehydration, or serious heart problems. If receiving iodinated contrast agents for radiologic testing, this medication should be discontinued for a specified period before and after the examination, and resumed only after confirming normal kidney function. This drug is also not recommended for pregnant or potentially pregnant women, or women who are breastfeeding. Regular monitoring of kidney function and blood creatinine levels is necessary while taking this drug, particularly for elderly patients or those with slightly impaired kidney function. This drug may cause gastrointestinal disturbances (diarrhea, vomiting, abdominal pain, etc.), urinary infections, genital infections, increased urination, and hypoglycemia, so any unusual symptoms should be reported to a physician immediately. Alcohol consumption should be avoided while taking this medication as it may increase the risk of lactic acidosis. Patients who are dehydrated or in a state of fluid deficiency, those with low blood pressure, or those suffering from cardiovascular disease should also exercise caution. If surgery is planned, this medication should be stopped 48 hours prior, and resumed only after confirming normal kidney function has been restored post-surgery. During the use of this medication, signs of hypoglycemia, symptoms of lactic acidosis (muscle pain, weakness, difficulty breathing, etc.), and signs of infection should be carefully monitored, and a physician should be notified promptly if any abnormalities occur. Lastly, this drug has not been established for safety and efficacy in children and is not recommended for individuals under 18 years of age. Elderly patients are at higher risk of decreased kidney function, therefore dosages should be adjusted, and regular monitoring should be conducted.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), lactic acidosis, ketoacidosis, angioedema, perineal necrosis, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty breathing, asthma attacks, respiratory distress with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

  • Hypoglycemia
  • urinary infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • taste disturbances
  • itching
  • rash
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • decreased and deficiency of Vitamin B12
  • fever
  • vascular stent stenosis
  • vascular stent thrombosis
  • weakness
  • chest discomfort
  • chest pain
  • weight loss
  • vulvar pruritus
  • insomnia
  • dizziness

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness and ensure safe usage.

Appearance and packaging

Appearance

White, oval, biconvex, film-coated tablet with a yellow tint

Package unit

10 tablets/box [10 tablets/PTP X 1], 60 tablets/box [10 tablets/PTP X 6], 60 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.